NCT00951795

Brief Summary

This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate CD4+ T-cells in whole blood over the measurement range expected for the intended population. The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

Same day

First QC Date

August 3, 2009

Last Update Submit

July 20, 2015

Conditions

HIV InfectionAIDSHIV Infections

Keywords

HIVAIDSCD4

Study Arms (2)

Adults

Adult men and women over age of 18

Pediatrics

Pediatric boys and girls ages 12-18

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The intended study population is individuals with confirmed diagnosis of HIV infection ≥ 12 years of age presenting to a physician's office or outpatient clinic.

You may qualify if:

  • years of age or older
  • Subject agrees to complete all aspects of the study

You may not qualify if:

  • Subject has already participated in this study at a previous date
  • Subject is enrolled in a study to evaluate a new drug
  • Patient unable or unwilling to provide informed consent
  • Vulnerable populations as deemed inappropriate for study by site principal investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fenway Community Health

Boston, Massachusetts, 02215, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

US(3)